Manager, Technical Release Manager
1Password
SDLC
Clinical Team Manager
ERGOMED
full-time
Posted on:
Location Type: Remote
Location: Remote • North Carolina • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- The Clinical Team Manager will be responsible for site level operational study management
- The CTM proactively identifies, resolves/mitigates, and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary
- Verifying and ensuring that project team members (CRAs, Site Managers, CTAs) are trained (e.g., GCP, SOP, indication, protocol, study specific procedures / requirements, etc.) to perform their assignments
- Developing, reviewing and revision of project documents (e.g., clinical monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.)
- Initiating corrective / preventative measures – e.g., update of study guidance documents, performing re-training, performing co-monitoring, etc.
Requirements
- Extensive clinical research lead experience in multiple studies
- Experience in managing Clinical part of studies in more than one region or equivalent study complexities
- Experience of phase 2/3 trials, ideally complex studies such as oncology or rare disease
- Able to work in a fast-paced small CRO environment and manage multiple projects
- Spanish language skillls and experience in LATAM preferred
- A minimum of a science-based bachelor’s degree
- Able to work effectively with minimal supervision
Benefits
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchproject managementGCPSOPclinical monitoring planCRF completion guidelinesstudy specific operating manualcorrective measurespreventative measuresco-monitoring
Soft skills
problem solvingrisk managementcommunicationleadershiptrainingorganizational skillsability to work independentlyadaptabilitymultitaskingcollaboration
